Kornimate/medical-research-clean huggingface dataset:
comparative effectiveness and prognostic factors of surgical and non-surgical management of lumbar spinal stenosis

Conditions: Lumbar Spinal Stenosis

Summary: introduction: lumbar spinal stenosis is a common cause of low back and leg pain in elderly impacting physical activity and quality of life. initial treatments are non-surgical options. if unsuccessful, surgery is advocated. the literature is not clear as to the outcome of surgery when compared to non-surgical treatment, and the optimal time for surgery is not explicit. materials and analysis: this observational study is designed to investigate the course of treatment, compare effectiveness of surgical and non-surgical treatment in patients with lumbar spinal stenosis, and identify prognostic factors for outcome in the context of current clinical practice. prospectively registered data on treatment, outcome and patient characteristics are collected from nationwide registers on health and social issues, a clinical registry of people with chronic back pain and hospital medical records. primary outcome is change in physical function measured by the zurich claudication questionnaire. secondary outcomes are changes in symptom severity, pain-related function, health-related quality of life, and general self-efficacy. all outcomes are measured at baseline, 6 months and 12 months follow up. comparisons on these variables will be made between those who undergo surgery for lumbar spinal stenosis and those not receiving surgery at 12 months follow up according to different analysis populations. prognostic factors include treatment allocation, back and leg pain intensity, comorbidity, duration of symptoms, pre-treatment function, self-rated health, income, general self-efficacy and magnetic resonance imaging graded compression of central stenosis. ethics and dissemination: the study has been evaluated by the regional committees on health research for southern denmark (s-20172000-200) and notified to the danish data protection agency (17/30636). all participants provide consent. findings will be disseminated in peer-reviewed publications and presented at national and international conferences following the guidance from the strobe and progress statement. potential sources of bias will be addressed using robins-i.


Eligibility criteria:
inclusion criteria: 1. \>60 years. 2. icd-10 diagnosis of degenerative lumbar spinal stenosis registered in the nationwide patient registry between january 1st - december 31st 2017. 3. included in the spinedata registry. 4. give consent to use patient-reported data for research purposes exclusion criteria: -
determination of the optimum delivery route for botulinum toxin a in patients with epiphora

Conditions: Epiphora

Summary: epiphora or excessive tearing is a significant disability for many affected patients diminishing their quality of life. there is a growing consensus that injection of botulinum toxin a (btx-a) into the lacrimal gland provides relief in patients with hyperlacrimation secondary to aberrant regeneration of the 7th nerve, and limited evidence that it might help to reduce normal tear production in patients with epiphora from anatomic or functional outflow obstructions. btx-a has been injected both transconjunctivally into the palpebral lobe of the lacrimal gland and transcutaneously into the orbital lobe. both delivery routes have been successful in symptom relief with minimal complications. however, the effectiveness of transconjunctival versus transcutaneous injections has not been systematically compared. also, whether the incidence of side effects is related to the dosage, concentration, or location of injection is unknown and has also not been systematically studied. the investigators plan to conduct a randomized clinical trial in patients with functional tearing comparing the transcutaneous delivery route of btx-a to the transconjunctival delivery route (the most common route described in the literature). the investigators will also compare the side effect profile of each delivery route.


Eligibility criteria:
inclusion criteria: * age over 18 years * ability to give informed consent * symptoms of epiphora in the setting of either a patent lacrimal outflow system or an obstructed outflow system for which the patient does not desire surgical therapy or is a poor surgical candidate exclusion criteria: * pregnancy * ocular motility abnormalities * prior ptosis, and/or strabismus surgery * more than 2 mm of pre-existing ptosis * inability to give informed consent * history of a bleeding disorder

Keywords: tearing, epiphora, botulinum toxin a
the role of a clinical pharmacist in lifestyle modification in type 2 diabetic patients with peripheral neuropathy

Conditions: Diabetic Peripheral Neuropathy

Summary: the aims of this study are to determine the prevalence of diabetic peripheral neuropathy among the diabetic patients, to determine the association between the clinical profiles of the diabetic patients (diabetes type, diabetes duration, hba1c, body mass index, hypertension, total cholesterol) and the diabetic peripheral neuropathy dpn and the rational poly pharmacy used to control pain.


Eligibility criteria:
inclusion criteria 1. aged 18 years or older. 2. both sex. 3. diagnosed with type 2 diabetes at least one year previously. 4. took at least one prescribed medication for diabetes. 5. diagnosed as diabetic peripheral neuropathy based on clinical exclusion criteria: 1. history of alcohol consumption. 2. thyroid gland disorder. 3. any kidney disorder. 4. any conditions that could confound assessment of pain due to diabetic peripheral neuropathy. 5. have foot injury or open sore. 6. pregnant females or who plan to become pregnant during the study period. 7. any serious medical condition that might prevent completion or hinder compliance with exercise. -
aim 3, adapting and implementing evidence-based breast cancer follow-up in primary care

Conditions: Cancer, Breast; Health Care Utilization

Summary: this mixed methods study evaluates the effectiveness of an organizational intervention to enhance implementation of strategies to increase breast cancer survivorship symptom and risk management.

aim 3 is a hybrid type 1 effectiveness-implementation cluster randomized study with a waitlist control in 26 primary care practices. this study uses a tailored combination of practice facilitation, expert consultation, collaborative learning events, and audit and feedback as intervention strategies, and a mixed-methods comparative case study learning evaluation for primary care practices to adapt priority recommendations of evidence-based activities for breast cancer survivorship care. intervention effectiveness will be assessed in two groups of clinics: 13 cases that will receive the implementation intervention and 13 waitlist controls. impact of this implementation will be measured using mixed methods to assess exploration, preparation, implementation and sustainment factors related to how organizational and contextual variables affect adoption, implementation and early sustainability for provision of follow-up care, symptom, and risk management activities at 6 and 12 months post implementation. aim 3 surveys 20 clinicians and staff members from 26 intervention practices (n=520) and conducts key informant interviews with 5 health care team members (who have participated in the survey; n=130) and 15 breast cancer survivors per practice (n=390; 5 per assessment point at baseline, 6 months and 12 months post intervention). medical records of 20 patients with a history of breast cancer per practice per assessment point at baseline, 6 months and 12 months post intervention will be randomly selected for review (n=1,560) to assess and compare comprehensive breast cancer follow-up care outcomes. sustainment will be measured through continued monitoring of the medical records for the 13 initial intervention practices at 18 and 24 months (n=520).

Eligibility criteria:
inclusion criteria: * self-identification as a staff member or patient who has had breast cancer in a participating practice exclusion criteria: * unable to speak, understand and/or read english * unable to provide informed consent
evaluation of the effectiveness and clinical utility of brain network activation (bna™) technology in the management of sport related concussion in youth and adolescents athletes.

Conditions: Minor Traumatic Brain Injury (TBI)

Summary: currently, there is no direct, reliable, bed-side, and non-invasive method for assessing changes in brain activity associated with concussion. event related potentials (erps), which are temporal reflections of the neural mass electrical activity of cells in specific regions of the brain that occur in response to stimuli, may offer such a method, as they provide both a noninvasive and portable measure of brain function. the erps provide excellent temporal information, but spatial resolution for erps has traditionally been limited. however, by using high-density electroencephalograph (eeg) recording spatial resolution for erps is improved significantly. the paradigm for the current study will combine neurophysiological knowledge with mathematical signal processing and pattern recognition methods (bna™) to temporally and spatially map brain function, connectivity and synchronization. the proposed study will provide additional evidence for the utility and contribution of the bna™ test (reflecting temporal and spatial changes in brain activity as well as brain functional connectivity associated with concussion) in concussion management.


Eligibility criteria:
inclusion criteria: * athletes ages 10-19, both genders, enrolled in nazareth academy , deerfield high school or the deerfield young warriors youth football program . exclusion criteria: * self-reported history of central nervous system injury or disease (examples will include, but will not be limited to, moderate or severe traumatic brain injury (tbi with a glasgow coma scale \< 13), epilepsy, seizures, brain surgery, or any positive neuroimaging results) * active head lice infection, open scalp wound * deafness, and/or blindness * sustained a concussion within six months * residual symptoms or deficits related to a previous concussion * long and thick hair that prevents the proper administration of an eeg cap.
ambulatory vs office bp management usual care for diagnosing and managing hypertension: a pilot study

Conditions: Hypertension

Summary: the purpose of this study is to compare the effectiveness of ambulatory blood pressure monitoring to usual care (blood pressure measurement in the office) in diagnosing and managing hypertension.

the usual strategy for detecting hypertension-repeated office blood pressure (bp) measurements-is inefficient and inaccurate. when paired with ambulatory bp monitoring (abpm), which takes a multitude of measurements over 24 hours, it is clear that office bp measurements may convey a falsely positive diagnosis known as white-coat hypertension. what is less well-known is that office bp measurements may also convey a falsely negative diagnosis termed masked hypertension (mh). that is, office bp may measure as normal, yet 24-hour ambulatory measurements show elevated bp. people with mh have cardiovascular risk that is similar to that of people with diagnosed hypertension, yet mh goes unrecognized, and therefore, untreated. ultimately, identifying the best strategy for accurately detecting hypertension is vital to improving overall bp control and reducing cardiovascular events. without a feasible abpm strategy, mh will continue to go unrecognized and untreated. participants enrolled in the study will be randomized to either the usual care group or the abpm-guided group. all participants will have a baseline abpm. abpm will be used to make a diagnosis and determine anti-hypertensive treatment in the abpm-guided group only. participants in the abpm-guided group will have a follow-up abpm in 2 months. all participants will have a final abpm 4 months after enrollment.

Eligibility criteria:
inclusion criteria: * age ≥ 30 years and ≤ 65 years * most recent (within 14 days) clinic systolic bp 126-150 mm hg * able/willing to wear a bp monitor for 24 hours on multiple occasions * able/willing to take daily anti-hypertensive medication if indicated * able to read and speak english exclusion criteria: * pregnant or trying to become pregnant * known heart disease * history of persistent atrial fibrillation * currently taking antihypertensive medication * currently taking simvastatin \> 20mg daily * clinician recommends against participation

Keywords: hypertension blood pressure ambulatory blood pressure monitoring
hit-stroke trial 2

Conditions: Stroke

Summary: people who had a stroke at least 6 months prior and who still have difficulty with walking will each be randomly assigned to receive either moderate or vigorous intensity walking exercise. both protocols will be performed individually with a physical therapist for 45 minutes, 3x/week for 12 weeks. measures including walking function will be assessed at baseline (pre), after 4, 8 and 12 weeks of training (12wk) and at 3-month follow up (3mopost), by raters who are unaware of the participant randomization.


Eligibility criteria:
inclusion criteria: * age 30-85 years at time of consenting * hemiparesis from ischemic and/or hemorrhagic strokes * most recent stroke for which participant sought treatment, at least 6 months prior to study consent * walking speed \<1.0 m/s on the 10-meter walk test * able to walk 10m over ground with assistive devices as needed and no continuous physical assistance from another person (guarding and intermittent assistance for loss of balance allowed) * able to walk at least 3 minutes on the treadmill at ≥0.13m/s (0.3 mph) * stable cardiovascular condition (aha class b, allowing for aerobic capacity \<6 metabolic equivalents) * able to communicate with investigators, follow a 2-step command and correctly answer consent comprehension questions exclusion criteria: * exercise testing uninterpretable for ischemia or arrhythmia (e.g. resting ecg abnormality that makes exercise ecg uninterpretable for ischemia and no other clinical testing from the past year available to rule out these conditions) * evidence of significant arrhythmia or myocardial ischemia on treadmill ecg graded exercise test in the absence of recent (past year) more definitive clinical testing (e.g. stress nuclear imaging) with negative result * hospitalization for cardiac or pulmonary disease within past 3 months * implanted pacemaker or defibrillator with an upper heart rate limit that would interfere with exercise testing or prescription, or with unknown limit * significant ataxia or neglect (score of 2 on nih stroke scale item 7 or 11) * severe lower limb spasticity (ashworth \>2) * known recent history (\<3 months) of unstable substance abuse or unstable mental illness * major post-stroke depression (patient health questionnaire \[phq-9\] ≥ 10) in the absence of depression management by a health care provider * currently participating in physical therapy or another interventional study targeting walking function * recent (\<2 weeks) or planned changes in lower limb orthotic or spasticity management * foot drop or lower limb joint instability without adequate stabilizing device, as assessed by a physical therapist * clinically significant neurologic disorder other than stroke or unable to walk outside the home prior to stroke * unable to walk outside the home prior to stroke * other significant medical condition likely to limit improvement or jeopardize safety as assessed by a physical therapist (e.g. joint contracture, gait limited by pain) * pregnancy * previous exposure to fast treadmill walking (\>3 cumulative hours) in the past year

Keywords: gait aerobic locomotion
increase understanding and safety of treatment

Conditions: Hematology; Oncology

Summary: purpose: the purpose of this study is to use a randomized controlled trial to explore whether the patients with cancers on clinical trials can use the health insurance app-my health bank to increase understanding and safety of treatment. it is of hope that the results of this study can help confirm whether cancer patients participate in clinical trials, learn to use the " health insurance app-my health bank ", can increase the safety of treatment, including the understanding of the disease , the understanding of the lab data, and the communication about contraindications and concurrent use of medications. the results of this research will help clinical healthcare professionals promote the use of my health bank, and improve the safety of clinical trials, as well as to increase the communications between patients, doctors and nurses. methods: in this study, cancer patients (hematology-oncology patients are the priority invitations) were invited to participate in clinical trials in the outpatient and inpatient units. after explaining that they agreed to participate in the study, they were randomlyassigned to the experimental group and the control group. intervention includes teach the subjects one-on-one to use the "my health bank" for 30 minutes (such as download, register, test, find information, etc.), and provide pre-recorded 1-minute instructional videos for viewing when needed at home. the intervention group also accepts to follow the use of my health bank app at home every two weeks for a period of two months. both groups will receive pre- and post-evaluations, including knowledge of the disease, understanding of lab data, and knowledge of medication safety (prohibited medicines and concomitant medications). post-intervention, the intervention group will also be evaluated on the "satisfaction and quality of technology use" of my health bank app. data analysis is expected to adopt intention-to-treat analysis (itt) method to compare the differences before and after intervention between the two groups to verify teach patients the clinical feasibility of using a my health bank and the effect of assisting patient care.


Eligibility criteria:
inclusion criteria: * over the age of 20, the subject voluntarily accepts this study and signs the consent form * participants in clinical trials of hematological tumor-related diseases (have been or are participating in it) * need to be literate and can communicate in chinese and taiwanese * have a mobile phone or electronic device to download the my health bank app and be willing to cooperate with it for at least two months of continuous use exclusion criteria: * i have downloaded the "my health bank app" and use well * cognitive impairment diseases (e.g. dementia) * the clinical trial protocol that originally participated in that it is not allowed to articipate in other interventional studies.

Keywords: randomized controlled trial application(app) my health bank
study of sputnik v covid-19 vaccination in adults in kazakhstan

Conditions: Covid19; Vaccine Adverse Reaction

Summary: this study will assess the safety, reactogenicity, and immunogenicity of gam-covid-vac (sputnik v) vaccine intended to provide acquired immunity against severe acute respiratory syndrome coronavirus 2 (sars-cov-2) causing coronavirus disease 2019 (covid-19). the vaccine contains two recombinant adenoviral vectors harbouring sars-cov-2 spike gene. the vaccine will be administered intramuscularly on a 2-dose prime-boost schedule. participants will be healthy adults aged greater than or equal to 18 years, voluntarily undergoing vaccination according to the guidelines of the ministry of healthcare of kazakhstan.

sputnik v (gam-covid-vac) is an adenoviral vector vaccine developed by the gamaleya research institute of epidemiology and microbiology (moscow, russia), registered and approved by the ministry of healthcare of kazakhstan. the vaccine incorporates two recombinant adenoviral (rad) vectors, rad5 and rad26, harbouring sars-cov-2 spike (s) gene. earlier phase i/ii clinical trials established that sputnik v is safe and efficacious when given intramuscularly in two sequential doses, as a rad26-s prime at day 0 followed by rad5-s boost at day 21, at 1x10\^11 particles per dose. the aim of the current study is to provide data on the safety, reactogenicity, and immunogenicity of sputnik v in adults vaccinated in kazakhstan using the established vaccination regimen. in addition, the effects of prior covid-19 exposure on the vaccine safety, reactogenicity, and immunogenicity will be assessed.

Eligibility criteria:
inclusion criteria: * participant must be healthy (in the physician's clinical judgment and as confirmed by medical records, and physical examination at screening). * willing to give informed consent, and answer short questionnaires on past exposure to covid-19 and post-vaccination reactogenicity. * willing to comply with the requirements of the protocol. exclusion criteria: * participant shows signs of an acute illness (excluding minor illnesses such as diarrhea or mild upper respiratory tract infection). * participant has a positive laboratory-confirmed test result for sars-cov-2 infection at screening. * deemed by investigators to be unlikely to complete study protocol.

Keywords: sputnik v gam-covid-vac vaccine safety vaccine reactogenicity vaccine immunogenicity
systematic and mechanism-based approach to rational treatment trials of blood cancer

Conditions: Hematologic Diseases; Treatment

Summary: this observational study evaluates if drug response testing can be performed within 7 days and analyzes the value of ex-vivo drug screening for hematological malignancies as a biomarker to predict outcome, clinical course and response to treatment.

targeted treatments have revolutionized care of individual diseases. while a new generation of targeted drugs is emerging in leukemia and lymphoma it remains clinical reality that most genetic information is not used for therapeutic stratification. this is in part based on the shortcomings of traditional biomarker discovery within clinical trials, where throughput is limited in both, drug number and sample size. if it were possible to map the variable pathway dependencies and drug sensitivity patterns in individual patients it is likely to become an asset to identify genotype-phenotype associations, understand the underlying complexities of molecular networks and further precision medicine stratification. to link clinical outcome and ex-vivo drug response assays, the investigators systematically measure pathway sensitivity and resistance of primary tumor cells ex-vivo using a diverse compound library for individual patients in need of treatment. by systematically analyzing ex-vivo drug response patterns, tumors should be functionally grouped, by response phenotype. while for the purpose of this study selection of a specific treatment will not be based on ex-vivo drug response assays, clinical response- and follow-up data of patients will be prospectively collected in parallel.

Eligibility criteria:
inclusion criteria: 1. diagnosis of a hematological malignancy: patients with leukemia, myeloma or lymphoma (e.g. all, aml, cll, t-pll, mcl, mm) who are in need of treatment and are willing to donate sufficient tumor material for ex-vivo drug sensitivity testing. 2. the treating physician needs to indicate treatment. 3. measurable disease burden according to criteria as mention in section 3. 4. treatment must be scheduled and the patient must be eligible for the planed treatment as judged by the treating physician. 5. availability of 5x10e7 cells from peripheral blood draws, bone marrow aspirations or lymph node biopsies. 6. patient's written informed consent present. 7. ability to understand the nature of the trial and the trial related procedures and to comply with them. exclusion criteria: 1. any condition, which precludes initiation of treatment (e.g. breast feeding, pregnancy, infections, etc.) as judged by the treating physician. 2. any coexisting medical or psychological condition that would preclude participation in the required study procedures, as judged by the treating physician. 3. no systemic cancer treatment except for cytoreductive pretreatment within 1 week of enrollment.

Keywords: biomarker signal transduction pathway deregulation outcome drug sensitivity testing targeted therapy genomic landscape